Punjab Blood Transfusion Authority (PBTA) Government of Punjab.PBTA is a regulatory body at the provincial level that ensures that the establishments performing any activity/process of the ‘vein to vein’ transfusion chain demonstrate the following main categories of action.
Punjab Blood Transfusion Authority (PBTA) Registration Form
Punjab Blood Transfusion Authority (PBTA) Registration Form is available at www.pbta.punjab.gov.pk
BLOOD BANK REGISTRATION FORM
Following documents attached with the registration form:-
1. Copy of CNIC (Responsible person/Incharge)
2. Two photographs (Responsible person/ Incharge)
3. Filled detailed information sheet for a blood bank license
(Downloadable from the website. Pbta.punjab.gov.pk)
4. Policy Manual / SOPs
5. Duty Roster of Technical Staff.
6. List of equipment with specifications.
7. Attested copies of degrees and certificates of all staff.
8. Original Challan after depositing the license fee Rs. 5500/- in NBP
in Head of Account C02871-Health Other Receipts.
9. Applications must be submitted or addressed to “Secretary Punjab Blood Transfusion Authority Inside Mental Hospital Off Jail Road Lahore” Incomplete applications will not be processed.
The Punjab Blood Transfusion Authority registers and licenses blood establishments performing any of the processes in the vein-to-vein transfusion chain, following the application received from an establishment. According to the law, only licensed institutions are allowed to collect, process, test, store, and issue blood. Licenses may be issued only to those establishments which comply with the law, rules, and regulations in force. Below, the key steps of the registration and licensing procedure are presented.
All applicants follow the procedures that are given below on this page.
- Reception of Application.
Any Blood Establishment that intends to collect, process, test, store or distribute blood and blood component applies for registration with the Blood Transfusion Authority before initiating operations. The application process involves the submission of the application form along with mandatory documents.
- Creation of Blood Establishment File
The Authority creates a file for each Blood Establishment with the application form and mandatory documents and, in compliance with the requirements for registration, the inspection team conducts an on-site inspection. All documents collected or received from a Blood Establishment are regularly filed in the Blood Establishment File.
- Authorization Inspection.
The essential actions included in the licensing inspection procedure are subdivided into those carried out before, during, and after inspection.
There are the following main points:
The inspection team assesses the scope and range of functions of the Blood Establishments by thoroughly reviewing the Blood Establishment File. The inspection team makes the Blood Establishments aware of. The objectives and scope of the inspection checklist to be used during the inspection. The date, time, duration, and schedule for meetings
During inspections, the inspection team Verifies the information included in the Blood Establishment File through a review of the mandatory documents on-site. Interviews staff to determine their competence Visits facility and observes/surveys the actual performance of collection, testing, processing, storage, and distribution of blood and blood components Fills out the inspection checklist
Upon completion of the inspection, the inspection team Conducts a meeting with the responsible person of the Blood Establishment to summarize its findings. The team presents its observations and preliminary findings, including areas of non-compliance as identified during the inspection along with supporting facts. In the event of any serious non-compliance which puts the quality and safety of the blood or blood components at risk; the inspector may order the immediate cessation of the establishment’s operations.
Prepares a provisional summary statement that reflects the findings of the inspection conducted including a short description of the Blood Establishment by area. All non-compliances are listed (even if corrective actions have taken place straight away) and reference to the law, rules, and regulations mentioned.
Indicates an approximate date for the availability of the written inspection report.
- Evaluation of Findings
The evaluation of findings is based on the law, rules, and regulations in force, with non-compliances, if observed, categorized as described below. The inspection report is prepared accordingly and sent to the Licensing Board for decision-making.
The decision, based on the evaluation of inspection, may be either authorization, proposition of corrective actions, or cessation of the operations of the establishment, temporarily or permanently. The decision is undertaken through a Licensing Board. The Board conducts periodic meetings (monthly). In-charges of inspected Blood Establishments may be invited for clarification on a case by case basis.
The BTA issues a license to the Blood Establishment.
The proposition of Corrective Actions
Depending on the overall performance and the type(s) of non-compliances observed, the BTA proposes corrective measures with a certain time frame. If required, a re-inspection may be scheduled.
Cessation of Operations
In the event of any serious non-compliance which puts the quality and safety of the blood or blood components at risk; the establishment’s operations may be ceased temporarily or permanently.
Submission of Report
The inspection team sends the inspection report to the Blood Establishment within a week after inspection. The conclusions clearly identify non-compliances, classified as critical, major, or other according to the preceding definitions. The inspector also provides a clear statement about the outcome of the inspection and, if required, a date by which the Blood Establishment is to submit an action plan (which includes a time schedule for rectifying the non-compliances).
Plan for Corrective Action
It is generally accepted that for major non-compliances the Blood Establishment must respond within 14 days; in case of ‘other’ significant non-compliances, within 30 days of the inspection. The response includes the specific steps which have been or will be taken to correct the failures mentioned above and to prevent their recurrence. In the case of critical non-compliances, corrective actions must be taken by the Blood Establishment without delay.
If corrective actions cannot be completed within the prescribed timeframe, the inspected Blood Establishment should state the reason for the delay and the time within which the corrections will be completed (the authority will decide upon the acceptability of the given time period). After this, the Blood Establishment has to report about the final corrections. Based on the evaluation of the action plan, the Secretary Blood Transfusion Authority takes one of the following courses of actions:
License is issued to the Blood Establishment;
A second site visit by the inspection team is authorized, or Additional information regarding corrective actions is requested from the Blood Establishment before authorization.
OFFICE OF THE SECRETARY, PUNJAB BLOOD TRANSFUSION AUTHORITY. INSIDE MENTAL HOSPITAL OFF JAIL ROAD LAHORE
PHONE NUMBER: 042-99201073- 03082818125